FDA-Device2020-06-17Class II
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Genicon, Inc.
Hazard
There is potential for the plastic optical tip to become detached from the metal shaft.
Sold states
US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
Affected count
0 (6 boxes with 5 units/per box in inventory)
Manufactured in
6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, United States
Products
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2020Don't want to check this manually?
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